High-Flow Oxygen in Reducing Shortness of Breath Caused by Exercise in Patients With Cancer

Dyspnea Clinical Trial

Official title:

High-Flow Oxygen for Exertional Dyspnea in Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02357134
• Other study ID #: 2014-0971
• Secondary ID: NCI-2015-0041820
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 17, 2015
• Est. completion date: May 31, 2023

Study information

• Verified date: November 2022
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized phase II trial studies how well high-flow oxygen works in reducing difficulty breathing during exercise (exertional dyspnea) in patients with cancer. Dyspnea is linked to decreased lung function, quality of life, and survival. High-flow oxygen is a device that delivers heated and humidified oxygen through the nose. This may be effective in reducing dyspnea, and may help patients' lungs function better and improve their quality of life.

Description:

PRIMARY OBJECTIVES: I. Obtain preliminary estimates of the effect size of oxygen and high flow rate on exertional dyspnea (modified Borg Scale adjusted for work rate and baseline dyspnea). SECONDARY OBJECTIVES: I. Determine the completion rate of a randomized controlled trial of exertional dyspnea in cancer patients. II. Obtain preliminary estimates of the effects of oxygen and flow rate on physiologic function (respiratory rate and oxygen saturation) and exercise capacity (work rate and exercise duration). OUTLINE: All patients undergo a baseline structured exercise session with air. Patients are then randomized to 1 of 4 treatments for a second session approximately 3 days later. ARM I: Patients receive high-flow oxygen via nasal prongs during a structured stationary bicycle exercise session. ARM II: Patients receive high-flow air via nasal prongs during a structured stationary bicycle exercise session. ARM III: Patients receive low-flow oxygen via a nasal cannula during a structured stationary bicycle exercise session. ARM IV: Patients receive low-flow air via a nasal cannula during structured stationary bicycle exercise session.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 74
• Est. completion date: May 31, 2023
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of cancer, with evidence of primary or secondary lung involvement
• Average dyspnea Borg Scale >= 4 of 10 with severe exertion over the past week
• Oxygen saturation > 90% on ambient air at time of assessment
• Able to communicate in English or Spanish
• Karnofsky performance status >= 50%
• Seen at Supportive Care, cardiopulmonary center, thoracic radiation oncology or thoracic medical oncology

Exclusion Criteria:

• Resting dyspnea modified Borg Scale > 7 of 10 at enrollment
• Severe obstructive lung disease (forced expiratory volume in 1 second [FEV1]/forced vital capacity [FVC] < 70% post bronchodilator and forced expiratory volume in 1 second < 30% predicted)
• Delirium (i.e., Memorial Delirium Rating Scale > 13)
• History of unstable angina or myocardial infarction in the last week
• Acute pulmonary embolus or pulmonary infarction in the last week
• Thrombosis of lower extremities in the last week
• Acute myocarditis, pericarditis, or endocarditis in the last week
• Symptomatic aortic stenosis or syncope in the last week
• Suspected dissecting aneurysm
• Severe untreated resting arterial hypertension (> 200 mmHg systolic, > 120 mmHg diastolic) at the time of enrollment
• Uncontrolled arrhythmias causing symptoms or hemodynamic compromise in the last week
• Uncontrolled heart failure in the last week
• Pleural effusion requiring thoracentesis within 1 week of study enrollment or scheduled during the study period
• Airway obstruction requiring stenting within 1 week of study enrollment or scheduled during the study period
• Pneumonia requiring antibiotics at the time of study enrollment

Related Conditions & MeSH terms

• Dyspnea
• Malignant Neoplasm
• Neoplasms

Intervention

Procedure:
• Oxygen Therapy
Receive high-flow oxygen
• Oxygen Therapy
Receive high-flow air

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Procedure:
• Respiratory Therapy
Receive low-flow oxygen
• Respiratory Therapy
Receive low-flow air

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Borg Scale Dyspnea Intensity at Isotime	Assessed Dyspnea using the Modified Borg Scale Dyspnea Intensity that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath") at Isotime. Measured the mean difference of Modified Borg Scale Dyspnea Intensity at isotime between the second exercise test (in which all patients received Low Flow Oxygen) and the third exercise tests (in which all patients received the assigned intervention).	End of second exercise test and end of third exercise test, approximately up to 12 minutes
Secondary	Slope of Modified Borg Scale Dyspnea Unpleasantness Over Time During Constant Work Exercise Per Minute (Third Test)	Dyspnea unpleasantness was measured using the Modified Borg Scale Dyspnea Intensity that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Dyspnea intensity was measured every minute. The number of minutes varied by patient, per test. It was measured as pairwise difference of slope (taking 'low flow air' arm as a reference). This linear mixed model was constructed based on the following: Dyspnea Unpleasantness at third test = Minutes + Study Arm + Study Arm*Minutes + Total work rate + Slope of Dyspnea Unpleasantness and Minutes at Second test + Minutes at second test.	Third exercise test, approximately up to 12 minutes
Secondary	Modified Borg Scale Leg Discomfort	Leg discomfort was measured using the Modified Borg Scale Leg discomfort that ranges from 0 ("no discomfort") to 10 ("worst possible discomfort") during the constant work exercise of third test. Leg discomfort was measured every minute. The number of minutes varied by patient, per test. It was measured as pairwise difference of slope (taking 'low flow air' arm as a reference). This linear mixed model was constructed based on the following: Leg Discomfort at third test = Minutes + Study Arm + Study Arm*Minutes + Total work rate + Slope of Leg Discomfort and Minutes at Second test + Minutes at Second test.	Third exercise test, approximately up to 12 minutes
Secondary	Exercise Endurance	The Exercise endurance was measured as a mean duration of constant work in minutes during third test. It was measured as pairwise comparison of mean difference of exercise duration (taking 'low flow air' as a reference). This linear mixed model was constructed based on the following: Time at third test = Study Arm + Minutes at Second test. Detail output from the mixed models	End of third exercise test, approximately up to 12 minutes
Secondary	Adverse Events	Adverse effects related to supplemental oxygen use were assessed using a numeric rating scale from 0 (not at all) to 10 (worst possible) before and after the study intervention. The mean change was measured before and after the 3rd test ranging between -10 (improvement) and +10 (deterioration).	Before and after 3rd test during intervention phase, approximately up to 12 minutes

External Links

•   MD Anderson Cancer Center Website